ST-Elevation Myocardial InfarctionPhase 2NCT00502528
Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction
A Phase 2 study testing BQ-123 in people with ST-Elevation Myocardial Infarction, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. The aim of the present study is to investigate the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Elevation Myocardial Infarction
- What is being tested?
- BQ-123
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteAustria
- Study dates
- May 2007to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI patients (defined as: Evidence of ischemic chest pain for >30 minutes within <12 hours and new ST-segment elevation for ≥2 mm in two or more contiguous electrocardiographic leads or in case of a true posterior infarction reciprocal ST-segment depressions in in V1 and V2 >1mm and/or elevated serum creatine phosphokinase or twofold elevation of troponin-T), aged 18 years and above, who undergo primary percutaneous revascularization (PCI) and have confirmed initial TIMI 0 or 1 in the infarct related coronary artery.
Who cannot join
- Significant liver disease
- Thrombolytic therapy
- History of prior myocardial infarction
- Current atrial fibrillation
- History of congestive heart failure
- History of migraine headache
Show all 15Show fewer
- Significant valvular heart disease, primary myocardial disease
- Cardiogenic shock (sRR <90mmHg or need for inotropic support)
- Child-bearing potential
- Inability to read, understand and sign the informed consent
- Life expectancy <3y
- Prior organ transplantation
- Medication with konazoles, ritonavir, rifampicin and sulfonyl-urea derivatives
- Participation in another clinical study
- Metal implants contraindicating CMR
Trial locations and contacts
1 site in 1 country.
About this study
Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. The aim of the present study is to investigate the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in patients with STEMI.
Patients are randomized to receive periinterventional intravenous BQ-123 or placebo.
Read the detailed description
Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. We have previously shown that thrombectomy in ST-elevation myocardial infarction (STEMI) accelerates ST-segment resolution, possibly by preventing distal embolization. Therefore, we analyzed the vasoconstrictor concentration of acute coronary thrombi, and found high concentrations of endothelin (ET) which correlated with the magnitude of ST-segment resolution within one hour of percutaneous coronary intervention (PCI). Furthermore, ET-receptor blockade by tezosentan significantly repressed vasoconstriction in an in-vitro model using porcine coronary artery rings incubated with coronary thrombus homogenates extracted from STEMI patients.
The aim of the present study is to investigate the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in patients with STEMI.
Methods: Fifty eligible patients will be randomized to receive periinterventional intravenous BQ-123 or placebo. The primary endpoint of the study will be microvascular function evaluated by cardiac magnetic resonance tomography.
- Conditions
- ST-Elevation Myocardial Infarction
- Being tested
- Placebo, BQ-123
- Keywords
- Infarction, Endothelin, Perfusion
- Medical subject headings
- ST Elevation Myocardial Infarction, Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called sodium salt
Peri-interventional
BQ-123Drug
Also called Cyclo(-D-Trp-D-Asp-Pro-D-Val-Leu) sodium salt
Peri-interventional
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2 | Active comparator | BQ-123 Receives: Drug: BQ-123 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion determined by CMR
Measured: 3 days
Secondary outcomes (10)
Final infarct size determined by CMR
Measured: 3 days
Left ventricular function determined by CMR
Measured: 3 days/ 6 months (6-months Remodeling-substudy)
Plasma NT-BNP
Measured: 30 days/ 6 months (6-months substudy)
Enzymatic infarct size (CK levels)
Measured: 3 days
ECG ST-segment resolution
Measured: 1 hour
Markers of inflammation
Measured: 24 hours/ 30 days
Major adverse cardiac events (MACE) (cardiovascular death, re-hospitalization for unstable angina and AMI, hospitalization for worsening heart failure)
Measured: 30 days
Liver function
Measured: 24hours/ 3 days/ 30 days
Event free survival
Measured: 6 months (6-months substudy)
Holter ECG
Measured: 3 days / 30 days (EP-substudy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2009
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Lang, Medical University of Vienna
- Investigators
- Irene M Lang, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502528
- Sponsor's protocol ID
- BQ123AMI12/06
- Status last verified
- Apr 2013
- First submitted
- 16 Jul 2007
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adlbrecht C, Andreas M, Redwan B, Distelmaier K, Mascherbauer J, Kaider A, Wolzt M, Tilea IA, Neunteufl T, Delle-Karth G, Maurer G, Lang IM. Systemic endothelin receptor blockade in ST-segment elevation acute coronary syndrome protects the microvasculature: a randomised pilot study. EuroIntervention. 2012 Apr;7(12):1386-95. doi: 10.4244/EIJV7I12A218.
PubMed 22522549
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelin Receptor Blockade in Acute ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00502528
- Acronym / sponsor ID
- BQ123AMI12/06
- Conditions
- ST-Elevation Myocardial Infarction
- Keywords
- Infarction, Endothelin, Perfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. The aim of the present study is to investigate the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in patients with STEMI.
Patients are randomized to receive periinterventional intravenous BQ-123 or placebo.
Detailed description
Background and Objective: Acute coronary syndrome is characterized by compromised blood flow at the epicardial and microvascular levels. We have previously shown that thrombectomy in ST-elevation myocardial infarction (STEMI) accelerates ST-segment resolution, possibly by preventing distal embolization. Therefore, we analyzed the vasoconstrictor concentration of acute coronary thrombi, and found high concentrations of endothelin (ET) which correlated with the magnitude of ST-segment resolution within one hour of percutaneous coronary intervention (PCI). Furthermore, ET-receptor blockade by tezosentan significantly repressed vasoconstriction in an in-vitro model using porcine coronary artery rings incubated with coronary thrombus homogenates extracted from STEMI patients.
The aim of the present study is to investigate the effect of ET-receptor blockade by BQ-123 on myocardial perfusion and infarct size as an adjunct to PCI-reperfusion therapy in patients with STEMI.
Methods: Fifty eligible patients will be randomized to receive periinterventional intravenous BQ-123 or placebo. The primary endpoint of the study will be microvascular function evaluated by cardiac magnetic resonance tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
| 2 | Active comparator | Drug: BQ-123BQ-123 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- STEMI patients (defined as: Evidence of ischemic chest pain for >30 minutes within <12 hours and new ST-segment elevation for ≥2 mm in two or more contiguous electrocardiographic leads or in case of a true posterior infarction reciprocal ST-segment depressions in in V1 and V2 >1mm and/or elevated serum creatine phosphokinase or twofold elevation of troponin-T), aged 18 years and above, who undergo primary percutaneous revascularization (PCI) and have confirmed initial TIMI 0 or 1 in the infarct related coronary artery.
Key exclusion criteria (15 listed)
- Significant liver disease
- Thrombolytic therapy
- History of prior myocardial infarction
- Current atrial fibrillation
- History of congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: sodium saltPeri-interventional | Drug | 1 |
| BQ-123Also: Cyclo(-D-Trp-D-Asp-Pro-D-Val-Leu) sodium saltPeri-interventional | Drug | 2 |
Primary outcome
Myocardial perfusion determined by CMR
Time frame: 3 days
10 secondary outcomes
Final infarct size determined by CMR
Time frame: 3 days
Left ventricular function determined by CMR
Time frame: 3 days/ 6 months (6-months Remodeling-substudy)
Plasma NT-BNP
Time frame: 30 days/ 6 months (6-months substudy)
Enzymatic infarct size (CK levels)
Time frame: 3 days
ECG ST-segment resolution
Time frame: 1 hour
Markers of inflammation
Time frame: 24 hours/ 30 days
Major adverse cardiac events (MACE) (cardiovascular death, re-hospitalization for unstable angina and AMI, hospitalization for worsening heart failure)
Time frame: 30 days
Liver function
Time frame: 24hours/ 3 days/ 30 days
Event free survival
Time frame: 6 months (6-months substudy)
Holter ECG
Time frame: 3 days / 30 days (EP-substudy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Results publication: PubMed 22522549Adlbrecht C, Andreas M, Redwan B, Distelmaier K, Mascherbauer J, Kaider A, Wolzt M, Tilea IA, Neunteufl T, Delle-Karth G, Maurer G, Lang IM. Systemic endothelin receptor blockade in ST-segment elevation acute coronary syndrome protects the microvasculature: a randomised pilot study. EuroIntervention. 2012 Apr;7(12):1386-95. doi: 10.4244/EIJV7I12A218.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene M Lang, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BQ-123 in people with ST-Elevation Myocardial Infarction, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial perfusion determined by CMR (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00502528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.